BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
FDA premarket approval P080011/S034 · decided 2015-01-22
Approval details
- PMA number
- P080011
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2014-12-15
- Decision date
- 2015-01-22
- Days to decision
- 38 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- CHANGE TO THE FREQUENCY OF WATER CONTENT TESTING FOR THE COMFILCON A SOFT, EXTENDED-WEAR CONTACT LENSES.
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